FDA 510(k)

Zimmer, Inc. Hip Joint Prostheses MR Labeling I

K-Number: K200823 · 2020-07-09

Decision Date2020-07-09

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Zimmer, Inc. Hip Joint Prostheses MR Labeling I is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2020-07-09 under 510(k) number K200823. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer, Inc. Hip Joint Prostheses MR Labeling I?

Zimmer, Inc. Hip Joint Prostheses MR Labeling I is a medical device that received FDA 510(k) clearance on 2020-07-09. The listed applicant is Zimmer, Inc.. The 510(k) number is K200823.

When did Zimmer, Inc. Hip Joint Prostheses MR Labeling I receive FDA 510(k) clearance?

Zimmer, Inc. Hip Joint Prostheses MR Labeling I received FDA 510(k) clearance on 2020-07-09, under 510(k) number K200823.

Who is the listed applicant for Zimmer, Inc. Hip Joint Prostheses MR Labeling I?

The FDA 510(k) record lists Zimmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zimmer, Inc. Hip Joint Prostheses MR Labeling I?

The FDA product code for Zimmer, Inc. Hip Joint Prostheses MR Labeling I is JDI.

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Other records listing Zimmer, Inc. as applicant

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing K261683Augment Off-Axis Instrument System K260831Z1 Hip System K251840Zimmer® Persona® Personalized Knee System K260182Avenir® Müller Stem; Avenir Complete™ Hip System K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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Related Devices (Code: JDI)

K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.